HK1155351B - An inserter - Google Patents

Description

Inserter

Technical Field

The present invention relates to an inserter for placing an intrauterine device or an intrauterine system in the uterus, and a kit (kit) comprising an intrauterine device and an inserter.

Background

Nowadays, various types of inserters have been developed for copper wire-containing mechanical intrauterine devices (IUDs) and intrauterine systems (IUS) with a drug-loaded cartridge. In the following, the IUD and IUS are used interchangeably, and when referring to one, it is understood that either of these can be used.

Most conventional inserters are configured to deliver the contraceptive device into the uterus in a contracted state. These inserters typically include: a cannula having a relatively narrow diameter and a rounded smooth end that is easily passed through the cervical canal and that does not damage or injure the fundus when in contact with the fundus (fundus); and a plunger disposed within the cannula. Prior to insertion of the contraceptive device (IUD or IUS), the contraceptive device is usually retracted into the insertion tube by means of a string(s) attached to the contraceptive device and used to remove the contraceptive device from the uterus, or by pushing the contraceptive device into the insertion tube with a plunger, and the inserter is provided with a special window to accommodate the contraceptive device in its expanded shape (see e.g. patent document GB 1403393). Subsequently, a cannula with an intrauterine device accommodated therein is introduced into the uterus through the cervical canal. When the contraceptive device is correctly placed, it is released either by pushing the plunger towards the uterus, or by holding the plunger steady and by pulling the cannula back outwards. Once expelled from the cannula within the uterine cavity, the contraceptive device should return to its original deployed shape.

To insert a relatively small or sufficiently flexible intrauterine device into the uterus in its initial deployed shape using a simple push-in technique, a simpler rod-like inserter has been proposed. With these inserters, it may be difficult to place and securely attach the IUS or IUD onto the inserter correctly and to manipulate the removal cord correctly.

European patent application EP 1691740 relates to an inserter with which the correct placement and directional stability of the contraceptive device in the inserter before and during insertion can be ensured, for example by shaping the front end of the plunger such that the IUS has a specific fixed form when pulled into the cannula. Therefore, the IUS does not twist during insertion.

European patent EP 798999 relates to an inserter with which the IUS can be correctly placed even if the elongated member of the T-shaped contraceptive contains an active substance, the diameter of the inserter being larger than the diameter of the elongated member of the copper wire IUD. The inserter comprises: a plunger; a handle attached to the plunger; a cord for removal of the IUS; a notch (cleft) on the end of the handle for locking the cord(s) so that the IUS remains immovable relative to the plunger; and a cannula surrounding the plunger. The IUS is pulled into the insertion tube by pulling the string, either by pushing the tube over the contraceptive device, or after manually locking the removal string in the notch. Limiting the relative movement of the plunger and the protective tube with one or more stop members ensures that the correct configuration of the IUS is achieved. The stop member ensures that the leading edge of the cannula is prevented from moving while the hemispherical tip of the T-wing (T-wing) remains partially uncovered by the cannula but still keeps the wings in a mutually compressed configuration. Such an inserter overcomes many of the problems of conventional inserters, but still requires manual manipulation and locking of the cord(s).

Furthermore, WO 2007/075086 shows an applicator (applicator) for insertion of an IUD, wherein the applicator has two recesses at one end for receiving and securing the flexible arms of the IUD during insertion of the IUD. Document NL 8601570 shows an IUD comprising a rod, one end of which is fixed to a ring of elastic material. When the IUD is inserted, the IUD is placed in the cannula such that the stem is inside the cannula and the ring is outside the cannula.

DE 19815552 and DE 8712168 describe an inserter for an intrauterine system, which inserter comprises a handle, an insertion tube and a frame slot provided at the end of the insertion tube. Patent document CA1033247 proposes a device for insertion into an intrauterine device comprising a hollow inserter tube and an open-ended cannula fitted on the inserter tube. Patent document EP 191957 discloses an assembly comprising an intrauterine device and an inserter, one end of which is open to form a recess or semi-cylinder to enable the insertion of the handle (stem) of the intrauterine device therein.

The inserters described in these documents overcome many of the problems with conventional inserters, but still require manipulation and manual locking of the cord(s). Moreover, these inserters are designed primarily for insertion procedures of conventional intrauterine devices which are inserted in a compressed configuration. Accordingly, there remains a need for an improved kit comprising an intrauterine system and an inserter.

Disclosure of Invention

It is an object of the present invention to provide a simple and easy to use inserter and a kit comprising an intrauterine system and an inserter for placing the intrauterine system into the uterus by at least partly solving at least some of the problems described above. It is, inter alia, an object of the invention to provide an inserter and a kit with which the cord does not need to be manipulated manually during insertion. It is yet another object of the present invention to provide an inserter with an improved system for locking and releasing the removal string of an IUS in the necessary steps of the insertion process. A typical inserter for an intrauterine system according to the invention comprises a handle and a cannula having a first end and a second end, and the cannula is arranged in connection with the handle. The inserter is characterized in that the first end of the insertion tube comprises at least one frame slot for receiving a frame of the intrauterine system.

A typical kit according to the invention comprising an inserter and an intrauterine system is configured as follows:

the inserter is an inserter according to the invention,

the intrauterine system comprises a treatment member and a continuous and closed frame, the treatment member being connected to the frame in at least one position thereof, and

the treatment member of the intrauterine system is at least mostly arranged inside the first end of the insertion tube and the frame of the intrauterine system is at least mostly arranged outside the first end of the insertion tube.

Drawings

Fig. 1 shows a diagrammatic view of an inserter as part of a kit according to one embodiment of the invention.

Fig. 2A and 2B illustrate the principle of operation of an inserter that is part of a kit according to one embodiment of the present invention.

Fig. 3A and 3B illustrate the principle of operation of an inserter that is part of a kit according to one embodiment of the present invention.

Fig. 4A and 4B illustrate a locking device that may be used in one embodiment of the present invention.

Fig. 5A and 5B show a locking device that can be used in another embodiment of the present invention.

Fig. 6A and 6B show a locking device that can be used in yet another embodiment of the present invention.

Fig. 7A and 7B illustrate a locking device that may be used in yet another embodiment of the present invention.

Fig. 8A and 8B illustrate a locking device that may be used in yet another embodiment of the present invention.

Fig. 9A, 9B, 9C and 9D illustrate an intrauterine system and its placement on an inserter according to some embodiments of the invention.

FIGS. 10A and 10B show some details of FIG. 9B

Detailed Description

A typical inserter for an intrauterine system according to the invention comprises a handle and a cannula having a first end and a second end, and the cannula is arranged in connection with the handle. The inserter is characterized in that the first end of the insertion tube comprises at least one frame slot for receiving a frame of the intrauterine system.

The invention thus provides an easy-to-use inserter and a kit comprising an intrauterine device and the inserter, with which only a few simple steps need to be performed to prepare for insertion and to mount and place the intrauterine system securely in the uterus.

In the description and claims of the present invention, a therapeutic member is a member capable of producing a therapeutic effect by, for example, releasing an active agent such as copper ions or hormones. Furthermore, the first end is generally the end which is closer to the uterus during insertion of the intrauterine system. The second end is an end opposite the first end. Furthermore, in describing the preferred embodiments of the present invention, the terms IUS or IUD and "removal string" are used, but these terms should not be construed as limiting the claims.

The cannula can be connected to the handle in at least two different ways. In fact, according to one embodiment of the present invention, the inserter is further characterized,

the first end of the handle has a longitudinal opening having a longitudinal axis parallel to the longitudinal axis of the inserter, a first end and a second end,

and the inserter further comprises:

a movable slider arranged in said longitudinal opening and having a first end and a second end,

-a plunger attached to the handle,

the second end of the cannula is attached to the slider.

According to another embodiment, the second end of the cannula is directly attached to the handle.

The longitudinal opening in the handle may also be very narrow and need not be symmetrically arranged on the handle with respect to the longitudinal axis.

A typical kit according to the invention comprising an inserter and an intrauterine system is configured as follows:

the inserter is an inserter according to the invention,

the intrauterine system comprises a treatment member and a continuous and closed frame to which the treatment member is connected in at least one position thereof, an

The treatment member of the intrauterine system is at least mostly arranged inside the first end of the insertion tube and the frame of the intrauterine system is at least mostly arranged outside the first end of the insertion tube.

In the following, several different embodiments of the invention are discussed, including an inserter and a kit. The information presented makes necessary modifications to the inserter and kit.

According to another embodiment of the invention, the treatment member is selected from the group consisting of a reservoir for the active agent, a wire, and combinations thereof. For example, the reservoir may consist essentially of an elastomer and an active agent, or the wire may be made of copper.

According to an embodiment of the invention, the reservoir of the intrauterine system essentially consists of an elastomer and an active agent. The reservoir may be, for example, a reservoir as described in patent documents WO 2003/017971, US 6,05,976, US 6,299,027 or WO 00/00550, the contents of which are hereby incorporated by reference.

The elastomer may be, for example, an elastomer composition comprising a silicone-based elastomer, a thermoplastic polyurethane elastomer, an ethyl vinyl acetate copolymer, a polyolefin-based elastomer, a silicone-containing thermoplastic polyurethane, or a mixture of at least two of these. The reservoir may also be of the core and film type, wherein the core and film are preferably made of an elastomeric composition.

Preferably, the intrauterine system further comprises a cord for removing, positioning or detecting the intrauterine system and at least one image enhancing device for improving the detection and/or positioning of the intrauterine system.

The image enhancement device may for example be selected from the group consisting of:

a) an inert metal coating covering at least a portion of the body of the intrauterine system;

b) an inert metal insert, clip, ring or sleeve fixedly disposed on a body of the intrauterine system;

c) metal, ferromagnetic powder or granules, or suitable metal or alkali metal salts, mixed during the synthesis step of the raw materials of the frame, core array (core matrix) or membrane of the intrauterine system, and

d) metal covers, connectors, adapters, clips, sleeves or retainers secured in place on the frame, and these devices may also be used to secure or attach the treatment member to the frame.

According to another embodiment of the invention, the treatment member is connected to the frame in at least one position. Furthermore, the intrauterine system may be connected to the inserter by means of, for example, at least one connection. The connecting portion is preferably designed to enhance the retention of the intrauterine system on the inserter before and during insertion of the intrauterine system.

The connecting parts may for example be hollow spheres adapted to receive pins, one of these connecting parts being provided on the intrauterine system and the other part on the inserter. Another option is to use a conventional ball and socket joint. A person skilled in the art can easily find a solution suitable for such a connection.

Thus, according to an embodiment of the invention, the first end of the insertion tube comprises at least one connection slot for receiving a connection part of an intrauterine system. Alternatively, the first end of the plunger may comprise a slot for receiving an intrauterine system (e.g. for receiving a second end of a frame or treatment member of the intrauterine system). The first end of the cannula may further comprise two diagonally symmetrical connection slots for receiving the coupling part of the intrauterine system. Of course, there may be more than two connecting slots, for example three, four, five or six connecting slots. The connecting portions thus preferably comprise portions adapted to fit into these connecting slots. The connecting portion can also be made to cooperate with the plunger. If a plunger is used, the plunger may be designed to receive a treatment element or frame.

According to the invention, the first end of the cannula comprises at least one frame slot for receiving a frame of the intrauterine system. The first end of the cannula may further comprise two diagonally symmetrical frame slots for receiving a frame of the intrauterine system. There may also be more frame slots, for example three, four, five or six frame slots. The frame slot may be parallel or non-parallel to the longitudinal axis of the cannula. The frame slot may be straight or slightly curved, for example, relative to the outer surface of the cannula, allowing the frame to be released. The frame slot is preferably thin enough to prevent the treatment member from slipping out of it, and is preferably long enough to allow the treatment member to move and the frame to expand/contract during the insertion step. The cannula is sized to receive the treatment member. The frame slot(s) and the connecting portion together ensure that the intrauterine system is securely fixed and in the correct configuration during insertion.

According to an embodiment of the invention, the frame of the intrauterine device has a shape selected from the group consisting of ring, circle, oval, spiral, torus (toroidal), triangle, polygon, almond, shield, and diamond. The frame is preferably also made of an elastic material, such as the elastomeric composition discussed above in relation to the reservoir. The frame may comprise, for example, a core material, a thin wire made of a material such as a metal memory material, or other suitable material, provided that the material has sufficient elasticity to be insertable into the intrauterine system, i.e. collapses during insertion through the cervix, but returns to its original shape once in place within the uterus.

According to one embodiment of the invention, the treatment member of the intrauterine system is preferably at least mostly arranged inside the cannula and the frame of the intrauterine system is preferably at least mostly arranged outside the cannula, when the inserter of the invention is in use.

According to another embodiment of the invention, the inserter further comprises a flange provided on the cannula. In order to accurately place the intrauterine device during insertion, the flange may be adjusted in correspondence with the depth of the uterus.

According to one embodiment of the invention, the first end of the opening and the first end of the slider form a first pair of stop members and the second end of the opening and the second end of the slider form a second pair of stop members.

Thus, a portion of the handle may include an opening having a first end and a second end and extending in a longitudinal direction of the plunger. The open first end may have a channel in which the cannula is slidable in a longitudinal direction. At the second, distal end (the end remote from the uterus), the cannula is attached to the slider or to a device (and which preferably forms at least part of the slider) that can be used to move the slider. With respect to the initial configuration, the front surface of the device forms together with the surface at the first end of the opening (the end towards the IUS) a first pair of stop members. To release the IUS after it has been positioned in the uterus, the cannula is pulled back through the plunger a distance determined by a second pair of stop members formed by the rear surface of the means for moving the slider and the surface on the second end of the opening.

The handle can have a variety of shapes and is designed to easily grip the inserter even with only one hand. Advantageously, the plunger attached to the handle is hollow or has an axially extending groove or aperture, thereby allowing the cord(s) to slide freely therein without risk of the cord becoming jammed between the plunger and the cannula. The first end (i.e. the front end) of the plunger is preferably suitably shaped with a suitable shape, such as a notch, recess, eyelet, passage or groove, to fit the lower end of the intrauterine system and to enable an optimal and secure placement of the intrauterine system on the plunger.

The plunger and the front part of the cannula (the part facing the uterus) may be straight or curved in order to adapt to the anatomy of the uterus. To avoid poking the uterus, the plunger and the front of the cannula are preferably formed of a flexible material.

The slider mechanism is preferably provided inside the handle and comprises at least one elongated element which is movable in the longitudinal direction of the plunger. According to one embodiment of the invention, the slider comprises means for moving the slider (the means preferably being part of the slider) and a cannula attached to the device. According to another embodiment of the invention, the slider comprises at least two elongated elements, preferably parallel to each other and joined at least in one position by a cross-member. The cross member may form a device, for example a knob or a switch, by means of which the slider can be moved. The handle may include one or more means for attaching the slider mechanism and facilitating movement of the slider, such as a support, shoulder, retainer, bracket, groove, or slot. The slider preferably comprises at least one structural element, such as an extension, capable of performing the possible necessary operations of the locking device to keep the string immovable during the storage phase or during the preparation step prior to insertion and/or to release the string(s) when the slider is moved to the return position.

The inserter according to the invention may thus further comprise locking means for reversibly locking the intrauterine system relative to the plunger, said locking means being controllable by the slider and/or the cannula. This means that the locking means may also be controlled by a portion of the slider and/or a portion of the cannula (e.g. an extension of one or both of the slider and the cannula). The disassemblable locking of the intrauterine system may be achieved by e.g. locking one or more removal cords of the intrauterine system, such that the intrauterine device remains stationary relative to the plunger during the necessary steps prior to and during insertion of the IUS but may be released after the precise positioning of the IUS in the uterus. Therefore, with the present invention, there is no need to manually manipulate the cord, thereby improving safety and hygiene.

The locking device is any one of such devices: actuated by the movement of the slider, the movement of the means for moving the slider or the movement of the insertion tube and able to fix the removal string(s) keeping the IUS in a stable position and/or release the string(s) after insertion of the IUS. In particular, the invention relates to a locking device comprising an object (object) which is able to repeatably prevent or allow movement of the cord(s) by being at least partially moved or pivoted (e.g. rotated about an axis or axle) from an initial position and which is attached to the handle vertically or horizontally. The article may have a variety of shapes and may be, for example, round or rod-shaped, wedge-shaped, polygonal, or rectangular with rounded or pointed corners. The surface of the article preferably includes one or more extensions of varying size and shape, such as knobs, ribs or switches. When the slider mechanism is moved backwards, a portion or extension of the slider or cannula is pressed against at least one extension of the object at a suitable location, thereby causing sufficient change in orientation of the extension of the object relative to the initial position to cause the cord(s) to be released. Preferably, the article has a slot or aperture through which the cord(s) pass.

The locking means may further comprise at least one counter portion (counter) against which the cord(s) are pressed by the object in the locked position, thereby releasably securing the cord(s). The opposing portion has a suitable shape adapted to mate with at least a portion of a surface of the article. One or more extensions of the member may be used to hold the member and the opposing portion in a fixed configuration until the slider is moved rearwardly to release the IUS. The opposite part preferably has a suitable design to keep the cord(s) in the proper orientation, e.g. a slot or a small hole for the cord(s) to pass through. Furthermore, the article and the at least one counterpart preferably have a length and diameter adapted to fit into the handle.

According to one embodiment of the invention, the locking device thus comprises:

-a main body portion,

-a first extension of the body portion having an abutment surface,

-an opposite portion adapted to form a blocking portion in cooperation with the body portion,

wherein the locking device is rotatably mounted on the inserter.

According to another embodiment of the invention, the main body part comprises an oblique opening or slot extending substantially through the entire diameter of the main body part, the opening or slot being adapted to receive at least one removal string of the intrauterine system.

The locking means may for example be mounted on the handle of the inserter. According to another embodiment of the invention, the opening or slot of the body portion is adapted to receive a removal cord of the intrauterine system.

According to still another embodiment of the present invention, a locking device includes:

-a main body portion,

-a first extension of the body portion having an abutment surface,

a second extension of the main body portion having a wedge shape,

-a counter-portion,

wherein the second extension is adapted to form a blocking portion together with the counter portion and the locking means is rotatably mounted on the inserter.

According to an embodiment of the invention, the shape of the body portion is substantially cylindrical or triangular or any other suitable shape.

According to one embodiment of the invention, the slider comprises an extension adapted to interface with an abutment surface of the first extension of the locking device body portion.

According to another embodiment of the invention, the locking device comprises a body part comprising a first extension and a second extension, the first extension and the second extension being arranged to substantially contact each other in their initial position to form a barrier, wherein the slider or a part of the slider, the cannula or a part of the cannula is arranged to protrude into the body part of the locking device in order to separate the first extension and the second extension from each other.

According to another embodiment of the present invention, a locking device includes:

-a first locking part and a second locking part movably mounted on the inserter, the first and second locking parts being arranged to substantially contact each other in their initial position to form a blocking part, an

-a first protrusion and a second protrusion, the first and second protrusions being arranged at the location of an inner surface of the cannula, an outer surface of the cannula, an inner surface of the slider or an outer surface of the slider.

Wherein the first and second protrusions are configured to move the first and second locking portions when the cannula is moved.

The locking means may also be welded, glued, cut, tethered or attached. Thus, the string may be attached to the body of the inserter by means of, for example, welding (e.g., by heat), gluing with glue, or bonding with an adhesive (e.g., glue). Thus, when the slider or the cannula is moved to release the intrauterine device, the slider or the cannula may release the attachment. When the slot for accommodating the cord in the release position is large, it is an option to employ, for example, a tether or other mechanical barrier means. The slider may also include a blade that cuts the cord line to release it from the insert.

It is obvious to a person skilled in the art that, in light of the above description, the locking means may be of any other type than those specifically listed above and combinations thereof.

In the preparation step stage, the string(s) is locked, however, when the slider is pulled backwards, the IUS is released by the slider automatically releasing the string. In contrast to previous inserters, the inserter according to the invention does not require manual manipulation of the removal cord at the preparation step stage and the insertion stage, thereby eliminating the possibility of erroneous operation by the user.

The invention also relates to the use of a kit according to the invention. Of course, any of the details and embodiments listed above may make necessary modifications to the use of the kit according to the invention.

The invention also relates to a method for placing an intrauterine system in the uterus of a patient, wherein the method utilizes a kit according to the invention.

The method comprises the following steps:

deep-examining the uterus using a probe to determine the exact depth of insertion,

-introducing the inserter into the uterus of the patient until the intrauterine system is in its correct position,

-removing the inserter from the uterus of the patient.

Advantageously, the method comprises as a second step providing a flange to indicate the correct insertion depth. Depending on the interposer, the method may further comprise the steps of: after the inserter is delivered into the uterus, the slider is moved towards the second end of the opening until the second end of the opening contacts the second end of the slider, thereby releasing the intrauterine system from the inserter.

In the following, an example of a method for placing an intrauterine system is given. For inserting the IUS only a few steps need to be performed. The sterile package is carefully opened in preparation for insertion. The IUS is placed in a deployed configuration at the forward end of a plunger or cannula. Preferably, the removal string(s) attached to the intrauterine device is fixed by a locking means, thereby holding the IUS in a stable and correct position until the IUS is released into the uterus.

The cannula is fed into the uterus until the IUS is in the correct position, which is predetermined by the use of a probe and preferably indicated by a flange set at the correct insertion depth. Depending on the inserter, the slider is moved towards the second end of the opening until the second end of the opening comes into contact with the second end of the slider, thereby releasing the intrauterine system from the inserter. The inserter is then removed and the IUS remains in place. Thus, the IUS can be easily and stably placed using the inserter.

Detailed description of the drawings

In the following description, the term "slider" and corresponding reference numerals are used to denote the slider itself and the device attached to the slider for moving the slider. The term "slider" is used for ease of reading.

Fig. 1 shows an overview of an inserter according to the invention. The inserter comprises a handle 3, a plunger 2 attached to the handle, a slider 5, a cannula 6 surrounding the plunger, the second end of the cannula being attached to the slider or to means for moving the slider. The inserter further comprises means for disengageably locking the string(s) (not shown) in such a way that the IUS remains immovable relative to the plunger during and during the necessary steps before insertion, and for releasing the string(s) and the IUS after insertion of the IUS. The inserter further comprises: an opening 8 in a portion of the handle; a channel 9 in which the cannula slides longitudinally; and a flange 4 which is adjustable such that its distance from the front end of the intrauterine system corresponds to the depth of the uterus.

The portion of the handle 3 near its first end comprises an opening 8 having a first end 8a and a second end 8b, which opening extends in the direction of the plunger 2, the first end of the handle 3 further having a channel 9 in which the cannula 6 slides in the longitudinal direction. In the initial configuration, the first end 5a of the slider 5 abuts the first end 8a of the opening 8 of the handle 3. The surface of the second end 5b of the slider 5 and the surface of the second end 8b of the opening 8 together form a pair of stop members. At the second end of the handle, i.e. at the end remote from the uterus, the cannula is attached to a slider 5. After insertion of the IUS, the slider and the cannula may be moved backwards until the surfaces 5b and 8b are in contact with each other. The locking means is arranged inside the handle 3 and is therefore not visible.

Fig. 2A and 2B illustrate the operating principle of an interposer according to one embodiment of the present invention.

Fig. 2A shows an inserter and an almond-shaped IUS 1, the inserter and IUS 1 being in the same form as they were in a sterile package. The IUS is positioned at the first end of the inserter (i.e. the front end, i.e. the end that protrudes into the uterus) such that the drug-containing storage portion of the intrauterine device is inside the insertion tube 6 and the bottom end, storage portion or ring portion of the frame abuts the end of the plunger (indicated by reference numeral 2 a). The means for moving the slider 5 are in the initial position and the removal string(s) in the inserter (indicated by reference numeral 7 in fig. 2B) are tightened and locked by the locking means.

Fig. 2B shows the process of releasing the IUS. The intrauterine device in the configuration shown in fig. 2A is introduced into the uterus until the IUS reaches the correct position, after which the intrauterine device is released from the insertion tube. While keeping the inserter stationary, the cannula is retracted towards the handle by moving the slider 5 backwards until the surface 5b of the slider abuts the surface 8b of the opening 8. The distance the slider and the cannula can move is chosen to clearly indicate the moment of complete release of the IUS from the cannula towards the handle.

Fig. 3A and 3B illustrate the operating principle of an inserter without a plunger and slider according to another embodiment of the present invention. The frame of the IUS is denoted by reference numeral 1a and the treatment member by reference numeral 1 b.

Fig. 4A and 4B illustrate a locking device according to an embodiment of the present invention. The locking means is preferably provided on the inside of the handle 3, on either inner surface of the handle. The locking means are used to secure the string(s) of the IUS and to release these strings.

Fig. 4A shows a locking device according to an embodiment of the invention, comprising a body part 10 having a substantially cylindrical shape and comprising an opening 12 extending diagonally therethrough. The string(s) 7 of the IUS pass through the opening 12. The body portion 10 is rotatably mounted on a shaft or axis (not shown) of the handle. The locking device further comprises a counterpart 11 for securing the string(s) between the counterpart and the body part in the locked position. Thus, the opposing portion has a suitable shape adapted to cooperate with a portion of the surface of the main body portion. When the slider is moved back to a suitable position, a part of the slider or an extension thereof is pressed against the extension 10a of the main body 10, thereby rotating the main body sufficiently to release the cord(s), as shown in fig. 4B.

Fig. 5A and 5B show a locking device according to another embodiment of the present invention. Fig. 5A shows a locking device similar to that shown in fig. 4A, but with a different configuration for the extension 10 a.

Fig. 6A and 6B show a locking device according to a further embodiment of the present invention. Fig. 6A and 6B are side views of a cylindrical-shaped lock device having a main body portion 13 including two extending portions 13a and 13B. The locking means is rotatable about an axis or shaft 14 and is preferably attached to the shorter side of the inner surface of the handle. The locking device further comprises a counterpart 15 to secure the string(s) 7 between the counterpart 15 and the extension 13 b. The opposite portion 15 has a suitable shape adapted to cooperate with a portion of the surface of the extension 13 b. When the slider is moved back to a suitable position, a part of the slider or an extension thereof is pressed against the extension 13a, thereby rotating the main body part enough to release the string(s), as shown in fig. 6B. In this case, the handle may further include a groove (not shown) for the string(s) to pass therethrough.

Fig. 7A and 7B illustrate a locking device according to an embodiment of the present invention. The locking device 16 comprises two extensions 16a and 16b for securing the cord, as shown in fig. 7A. When the slider 5 and the cannula 6 are moved backwards, the slider and/or the cannula at least partly extend into the locking means, so that the locking means are spread apart enough to separate the extensions and release the string, as shown in fig. 7B.

Fig. 8A and 8B show a locking device according to another embodiment of the present invention. As shown in fig. 8A, the locking device comprises two parts 17a and 17b for securing the line, which parts can be moved or rotated from their initial positions. The slider 5 has two extensions 18a and 18 b. When the slider 5 and the insertion tube 6 are moved backwards, the slider extension turns the locking portions 17a and 17B apart from each other enough to release the cord, as shown in fig. 8B.

Fig. 9A and 9B show an intrauterine system and its placement on an inserter according to an embodiment of the invention. The intrauterine system has a frame 1a and a treatment member 1b, which is placed in an insertion tube 6. The intrauterine system is connected to the inserter by a connection 19. The first end of the cannula 6 comprises a connecting slot 20 for receiving the connecting portion 19. The treatment component is substantially completely disposed in the frame slot 21 and the frame is substantially only partially disposed in the frame slot 21.

Fig. 9C and 9D show another intrauterine system and its placement on an inserter according to another embodiment of the invention. The intrauterine system has the same parts as fig. 9A and 9B. The treatment member is disposed substantially entirely within the cannula and the frame is disposed substantially entirely outside the cannula.

Fig. 10A and 10B show some details of fig. 9B, i.e. the first end of the cannula 6 and the connection part of the intrauterine system to the cannula.

Claims (12)

1. An inserter for an intrauterine system comprising:

-a handle (3), and,

-an insertion tube (6) having a first end and a second end and being arranged in connection with the handle, and the first end of the insertion tube (6) comprising at least one frame slot for receiving a frame of an intrauterine system,

it is characterized in that the preparation method is characterized in that,

-the first end of the handle (3) has a longitudinal opening (8), the opening (8) having a longitudinal axis parallel to the longitudinal axis of the inserter, a first end (8 a) and a second end (8 b),

and the inserter further comprises:

-a movable slider (5) arranged in said longitudinal opening (8) and having a first end (5 a) and a second end (5 b),

-a plunger (2) attached to the handle (3),

the second end of the cannula is attached to the slider (5).

2. An inserter according to claim 1, characterised in that the first end of the insertion tube (6) comprises at least one connection slot (20) for receiving a connection part of an intrauterine system.

3. Inserter according to claim 1, characterized in that the first end of the plunger (2) comprises a slot for receiving an intrauterine system.

4. An inserter according to claim 1, characterized in that the first end (8 a) of the opening (8) and the first end (5 a) of the slider (5) form a first pair of stop members and the second end (8 b) of the opening (8) and the second end (5 b) of the slider (5) form a second pair of stop members.

5. An inserter according to claim 1, characterized in that the inserter further comprises a flange (4) provided on the cannula (6).

6. An inserter according to claim 1, characterised in that the first end of the insertion tube (6) comprises two obliquely symmetrical connection slots (20) for receiving the connection part (19) of the intrauterine system (1).

7. An inserter according to claim 1, characterized in that the first end of the insertion tube (6) comprises two diagonally symmetrical frame slots for receiving a frame (1 a) of an intrauterine system (1).

8. An inserter according to claim 1, characterised in that the inserter further comprises locking means for the releasable locking of the intrauterine system relative to the plunger by means of a removal string of the intrauterine system, and that the locking means is controlled by the slider and/or the insertion tube.

9. A kit comprising an intrauterine system and an inserter according to claim 1, wherein,

-the intrauterine system (1) comprises a treatment component (1 b) and a continuous and closed frame (1 a), the treatment component (1 b) being connected to the frame (1 a) in at least one position, and

-the treatment component (1 b) of the intrauterine system (1) is at least mostly arranged inside the first end of the cannula (6), and the frame (1 a) of the intrauterine system (1) is at least mostly arranged outside the first end of the cannula (6).

10. The kit according to claim 9, characterized in that the treatment component (1 b) is selected from the group consisting of a reservoir for an active agent, a wire and a combination of both.

11. The kit of claim 10, wherein the reservoir is comprised of an elastomer and an active agent.

12. The kit of claim 10, wherein the wire is made of copper.